Director, Development Quality Assurance: Vendor Oversight

at  Alexion PharmaceuticalsInc

GENERAL ACCOUNTABILITIES

• Ensuring own tasks are performed to current practices and in accordance with company policies, standards, SOPs, and guidelines.
• Assists in inspection readiness and preparation, and/or directly supports regulatory agency inspection. Assists in coordination of responses to any findings, as applicable.
• Contributes to Due Diligence activities.
• Lead a team of staff who will be responsible for the operational aspects of Vendor Quality Oversight, Quality Governance, Documentation, and Training.
• Accountable for development, coaching, and mentoring of assigned staff and achievement of performance standards, capability, and effective line management.
• Maintaining knowledge of relevant industry information affecting quality and compliance arena.
• Involved in and may lead the development and/or revision of QA processes, projects, and tools.

THIS IS WHAT YOU WILL DO:

As part of the Development Quality Assurance Team, you will drive Quality Culture with stakeholders by partnering on quality topics, embedding a quality mindset, and executing on continuous improvement opportunities. You will be responsible for managing business relationships with defined stakeholder groups and leaders in Development, Regulatory and Safety functions and for the strategic development and delivery of risk-based quality management and vendor quality oversight for internal and external business partners.